Containers for body fluid collection and storage are known in many different versions. Among such containers are blood collection devices provided as blood collection tubes. State of the art blood collection tubes have commonly been provided with a thick rubber stopper also referred to as a cap which can be pierced with sharp needles using much force. The collection tubes are used as primary containers in laboratory analyzers. Today, the “usual” practice in laboratories is for the blood collection tubes to be opened before they are placed in an analysis machine in that the cap is removed either manually or using a decapper.
Body fluid containers with caps have been found whereby the rubber stopper is pre-pierced with a plastic device creating an opening through which pipetting is possible. Examples include devices disclosed in U.S. Pat. Nos. 5,240,679 and 5,081,872. Other devices and machines are known from U.S. Pat. No. 4,974,457 and WO 90/11752. Both processes mentioned above use disposable plastic parts. Furthermore, there are methods which press a washable hollow needle through the rubber cap which one may then pipette through (see U.S. Pat. No. 5,270,211). All of the systems were not able to establish themselves and have disappeared from the market once more.
The disadvantages of the prior art devices are that both of the above methods require a special device and particular equipment in order to provide the considerable force necessary to penetrate the cap. This can regularly lead to breakages in the tube container and the resulting contamination of the device, which is the exact opposite of the desired aim, namely a more or less contamination-free pipetting from “closed” tube containers. The other methods had the disadvantage of the hollow needle which must be cleaned or in cases of direct pipetting through the vacutainer's stopper, the forces necessary are particularly high and therefore it is not possible to pipette small volumes accurately due to the negative pressure which was thereby created in the tube container. A further disadvantage of existing solutions is that tube containers which do not have the device mentioned above are normally opened (decapped) before they are placed in the analysis equipment and have to receive a new closure (be recapped) prior to storage in a refrigerator. This has to be done for each subsequent analysis.
U.S. Pat. No. 6,116,445 discloses a sealing cap for the mouth of a container which facilitates both the sealing of new bottles containing unused contents, and the re-sealing of those bottles already in use so as to preserve their contents. The sealing cap includes an inner cap and an outer cap. The inner cap includes a shielding plate which is fixed on the mouth of a container, and an annular strip which is provided at the lower end of the outer circumferential wall of the inner cap. The outer cap, which is fixed on the inner cap, includes a top lid, and a main cap with a guide tube having a lower-end sharp edge located opposite the shielding plate. By removing the annular strip from the inner cap and pressing down the outer cap, the lower end of the outer cap engages the outer circumference of the mouth of the container, and at the same time, the lower-end sharp edge of the guide tube pierces the shielding plate. The user then opens the top lid of the outer cap to access the contents of the container.
From U.S. Pat. No. 6,024,234 a cap member having an annular wall and a top wall disposed within and connected to the annular wall is known. An arcuate pierce-plow member is disposed on an upper surface of the top wall at a position spaced from the annular wall. The pierce-plow member includes a piercing member disposed adjacent to the substantially flat portion of the plow base member. In an inverted, operative position relative to the container having a pierceable membrane which fluidly seals the mouth, the cap member can be used to pierce the pierceable membrane by rotating the cap member.